Pilot Study of the Efficacy & Safety of Natural Eggshell Membrane (NEM) for Joint & Connective Tissue Disorders
A Single Arm Pilot Study to Evaluate the Effectiveness of Eggshell Membrane Compositions for the Treatment of Pain Associated With Connective Tissue and Joints
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell Membrane (NEM) for the treatment of joint and connective tissue discomfort, pain, and flexibility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2003
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedSeptember 7, 2023
February 1, 2016
2 months
September 8, 2008
September 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure of this study was to evaluate the mean effectiveness of NEM® in relieving general pain associated with moderate joint & connective tissue disorders.
7 & 30 days
Secondary Outcomes (3)
Additional outcome measures were to evaluate flexibility
7 & 30 days
Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
7 & 30 days
To evaluate pain associated with the range of motion (ROM) evaluation.
7 & 30 days
Study Arms (1)
NEM Treatment
EXPERIMENTALNEM, 500 mg, once daily, orally for 30 days.
Interventions
Eligibility Criteria
You may qualify if:
- patients seeking relief of mild to moderate pain due to joint or connective tissue (JCT)disorders.
- subjects must have had persistent pain associated with a JCT disorder.
- subjects were required to suspend all current pain relief medications.
- Subjects that were currently taking analgesic medications were eligible to participate in the studies following a 14 day washout period for NSAIDs, a 7 day washout for narcotics, and a 90 day washout for injected steroids.
- subjects currently taking glucosamine, chondroitin sulfate or MSM were only eligible after a 3-month washout period.
You may not qualify if:
- Patients were excluded if they were currently receiving remission-inducing drugs such as methotrexate or immunosuppressive medications or had received them within the past 3 months.
- body weight 250 pounds or greater.
- a known allergy to eggs or egg products.
- pregnant or breastfeeding women.
- subjects previously enrolled in a study to evaluate pain relief within the past 6 months or currently involved in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product, within 30 days of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robinson Family Clinic
Carthage, Missouri, 64836, United States
Related Publications (1)
Ruff KJ, DeVore DP, Leu MD, Robinson MA. Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies. Clin Interv Aging. 2009;4:235-40. doi: 10.2147/cia.s5797. Epub 2009 Jun 9.
PMID: 19554094RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin J Ruff, Ph.D., MBA
ESM Technologies, LLC
- PRINCIPAL INVESTIGATOR
Mark A Robinson, D.C.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 10, 2008
Study Start
October 1, 2003
Primary Completion
December 1, 2003
Study Completion
January 1, 2004
Last Updated
September 7, 2023
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share